A wide variety of medical procedures involve the introduction of catheters, endoscopes, and other devices through natural lumen and artificially created passageways in the body. Certain applications require creating a device path through a sphincter or narrow body lumen, or through a long, tortuous pathway. Conventional distal axial advance (i.e., pushing) of a device is sometimes unable to reach a desired treatment or diagnostic site, and may in any event cause discomfort to the patient or trauma to delicate or sensitive tissues as the device is being advanced.
Lubricants and lubricious polymers or other coatings can reduce these effects, but not always to a sufficient degree. In the biliary system, as one example, passing a biliary catheter through the ampulla of Vater and into the common bile duct often results in swelling and subsequent closure of the opening, compromising normal drainage and making subsequent access difficult. Similar problems with discomfort or edema or failure to achieve proper device placement can be experienced by the patients when other anatomical sites are being accessed, for example, in the nasal passages, urethra, small intestine, colon, rectum, etc. While patient comfort may not be an issue when navigating internally such as within the biliary tree, the introduced device may be difficult or even impossible to advance as a result of frictional forces acting against it, especially since these obstructions and narrowed passages often cannot be adequately visualized.
Besides the biliary system, a variety of other sites within the body present an opportunity for improved access, patient comfort and reduced trauma during the introduction of a device. For example, the nasal passages are especially sensitive and recent trends have brought about an increase in the number of devices, such as endoscopes and tubes, being introduced via that route concomitant with the use of analgesics or sedatives to reduce patient discomfort.
Another setting where improved access would be important is for any of a variety of diagnostic or therapeutic procedures in the lower gastrointestinal tract. Accessing the small intestines is a significant challenge with current endoscopic technologies. The intestines are substantially unconstrained, mobile and follow a tortuous path so it is difficult to advance a pushable device through the intestinal lumen. Using an enteroscope to access the intestines can often provide access to the proximal region and the newer double balloon enteroscopes can access more distally by using the two balloons to push and pull against the wall of the intestines. However, both methods rely on applying a pushing force on the device or using the device to apply force against the walls of the intestine to advance the devices. Using a device as described herein would enable deployment of a device throughout the small intestine with less force acting on the intestine. The device as described could be used as a guide conduit for advancing an enteroscope or other device or it could deploy a guide wire or deliver therapeutic or diagnostic devices to affect treatment of the small intestine.
Therefore, what is needed is a medical device introducer system that can be incorporated into or used with a variety of catheter(s), sheath(s), endoscope(s) or other medical devices to permit the safe and comfortable passageway into and/or through a bodily passage to a remote procedure site.